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U.S. Approves First Cannabis-Based Drug for Epilepsy

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The U.S. Food and Drug Administration has approved the first cannabis-based drug to treat severe forms of epilepsy in children.

Developed by U.K. based company GW Pharmaceuticals Plc, the drug Epidiolex will be available to patients age 2 and older who are diagnosed with Dravet syndrome and Lennox-Gastaut syndrome, both early onset forms of epilepsy and extremely severe.

“This is an important medical advance,” FDA Commissioner Dr. Scott Gottlieb said. “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use.”

Epidiolex

Epidiolex is made up of a purified cannabidiol, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the compound that provides users with the ‘high’ effect. Unlike recreational marijuana, Epidiolex won’t give users the usually side effects, and is cited strictly for treating DS and LGS.

“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” said Gottlieb.

Epilepsy affects nearly 3.4 million Americans, and 65 million people worldwide. According to the National Institute of Neurological Disorders and Stroke, “in epilepsy, the normal pattern of neuronal activity becomes disturbed, causing strange sensations, emotions and behavior or sometimes convulsions, muscle spasms and loss of consciousness.” These strange sensations are seizures, and vary in degrees of severity.

According to the Dravet Syndrome Foundation, “Dravet syndrome is a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures.” Only about 1 in 16,000 people are diagnosed with DS. Seizures are prominent during the first year of life, but developmental delays generally don’t appear until the second or third year. Like other forms of epilepsy, DS requires several attempts to treat it with medication, but they often result in patients switching from one medication to the next, or not completely treating it.

Children with Lennox-Gastaut syndrome suffer from tonic (stiffening) and atonic (drop) seizures. While LGS accounts for only 2-5 percent of epilepsy in children, seizures are extremely difficult to control and most patients will need life-long treatment.

According to the Epilepsy Foundation, a medial study was performed to test Epidiolex. Over the course of 12 weeks, participants ranging from ages 2-26 years old (11 being the average age),  saw on average a 54 percent decrease in seizures. Previous to this experiment, none of the participants saw any improvement from other drugs that are currently on the market.

Epidiolex could possibly save children with DS and LGS. According to Reuter’s, “Epidiolex’s launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW to begin selling it.”

GW Pharmaceuticals has yet to set a price for the medication, but promises it will work with health insurances to ensure the medicine is covered.

Elizabeth Nouryeh

Writer for Hers Magazine. Poet. Lover of words. Bears, beets, Battlestar Galactica.

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